Keep out of the reach of children.

Read carefully the enclosed insert before use.

In case of any unexpected reaction consult your doctor or pharmacist.

PART I. INFORMATION LEAFLET FOR PATIENT

COMPOSITION: Each lozenge contains:

Active ingredient: Benzalkonium chloride………………………………..1 mg

Excipients: Sorbitol, mannitol 60, aspartam, peppermint flavor powder, colloidal anhydrous silica, magnesium stearate, menthol.

DESCRIPTION OF PRODUCT:

Lozenges in round shape, white in color, has the word “STAR” on both sides, lozenges is intact.

DESCRIPTION OF PACKAGING:

– Box of 2 alu bags, each alu bag contains 1 blister x 12 lozenges

– Box of 5 alu bags, each alu bag contains 1 blister x 12 lozenges

– Box of 10 alu bags, each alu bag contains 1 blister x 12 lozenges

WHAT IS THE MEDICINE USED FOR:

STAR BENKO is used for the topical treatment of infections in the oral cavity and pharynx such as sore throat, stomatitis, gingivitis.

HOW MUCH AND HOW OFTEN SHOULD YOU USE THIS MEDICINE:

Administration:

STAR BENKO is used inside the mouth. The lozenge should be allowed to dissolve slowly inside your mouth.

Lozenges should not be used just before or during meal.

Dosage:

– Adults and children > 12 years old: Every 2 to 3 hours 1 lozenge. The maximum daily dose is 6-8 lozenges.

– Children 10 to 12 years old: Every 3 to 4 hours 1 lozenge. The maximum daily dose is 6 lozenges.

– Children 4 to 10 years old: Every 3 to 4 hours 1 lozenge. The maximum daily dose is 4 lozenges.

– Do not administer to children under 4 years of age.

The usual duration of use of the product for:

– Sore throat: 5 days

– Stomatitis or gingivitis: 7 days.

WHEN SHOULD YOU NOT TAKE THIS MEDICINE:

Do not use STAR BENKO if:

– You are allergic to any components of the medicine.

– Children under 4 years old.

SIDE EFFECTS:

Local irritation.

Rare (may affect up to 1 in 1000 people):

Gastrointestinal disorders: Nausea and diarrhea may occur, particularly at higher doses than prescribed.

Very rare (may affect up to 1 in 10000 people):

Skin and subcutaneous tissue disorders: Hypersensitivity reactions such as irritation and skin rash.

In case of any unexpected reaction consult your doctor or pharmacist.

WHAT OTHER MEDICINE OR FOOD SHOULD BE AVOIDED WHILST TAKING THIS MEDICINE:

Lozenges may not be used together with milk, since the milk decreases the antimicrobial effectiveness of benzalkonium chloride.

WHAT SHOULD YOU DO IF YOU MISS A DOSE:

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

HOW SHOULD YOU KEEP THIS MEDICINE:

Store at temperature below 300C, in a dry place, protect from light.

SIGNS AND SYMPTOMS OF OVERDOSE:

Taking too much STAR BENKO can cause the following symptoms: Nausea, vomiting, diarrhea, excessive sweating and intense thirst.

WHAT TO DO WHEN YOU HAVE TAKEN MORE THAN THE RECOMMENDED DOSAGE:

If you take more than the recommended dose of STAR BENKO, you should:

• Talk to your doctor or go to a hospital straight away.
• Remember to take medicine that is left with you or medicine pack so the doctor knows what you have taken.

PRECAUTIONS THAT SHOULD BE TAKEN WHEN TAKING THIS MEDICINE:

For more serious infections accompanied by fever, severe sore throat, headaches or vomiting, you have to contact the doctor if the condition does not improve after 3 days.

Do not take STAR BENKO more than the recommended dose.

This drug contains:

– Sorbitol: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this drug.

– Aspartam: Patients with phenylketonuria and patients who have to limit phenylalanine intake should not use this drug.

Pregnancy and lactation: The use of this drug during pregnancy and lactation is not recommended due the lack of information.

Effects on ability to work: The product has no influence on the ability to drive or operate machinery.

WHEN SHOULD YOU CONSULT YOUR DOCTOR OR PHARMACIST:

In case of overdosage or adverse drug reactions.

When you are taking other drugs or foods.

For further information, consult your doctor or pharmacist.

SHELF-LIFE OF DRUG: 36 months from manufacturing date. Do not use after expiry date.

NAME, ADDRESS, LOGO OF MANUFACTURER: